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Chronic Pancreatitis. Effect of Pioglitazone on Endocrine Function, Exocrine Function & Structure, Pain & Life Quality

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ClinicalTrials.gov Identifier: NCT00782795
Recruitment Status : Completed
First Posted : October 31, 2008
Results First Posted : December 11, 2017
Last Update Posted : January 11, 2018
Sponsor:
Collaborators:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Takeda Pharmaceuticals North America, Inc.
Information provided by (Responsible Party):
Matthew DiMagno, MD, University of Michigan

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Chronic Pancreatitis
Insulin Resistance
Normal or Mildly Abnormal Stool Fat Levels
Interventions Drug: Pioglitazone
Drug: Placebo
Enrollment 64
Recruitment Details 39 screen fails did not go on to randomization
Pre-assignment Details  
Arm/Group Title Pioglitazone Sugar Pill (Placebo)
Hide Arm/Group Description

30 mg pioglitazone (Actos) tablet taken once daily for 48 weeks.

Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks.

1 sugar pill (placebo) taken once daily for 48 weeks.

Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks.

Period Title: Overall Study
Started 17 8
6 Weeks (1st Apptment) 16 7
24 Week Appointment 16 7
Completed 16 6
Not Completed 1 2
Reason Not Completed
Withdrawal by Subject             1             2
Arm/Group Title Pioglitazone Sugar Pill (Placebo) Total
Hide Arm/Group Description

30 mg pioglitazone (Actos) tablet taken once daily for 48 weeks.

Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks.

1 sugar pill (placebo) taken once daily for 48 weeks.

Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks.

Total of all reporting groups
Overall Number of Baseline Participants 17 8 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 8 participants 25 participants
52.35  (7.61) 48.37  (9.83) 51.08  (8.39)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 8 participants 25 participants
Female
5
  29.4%
2
  25.0%
7
  28.0%
Male
12
  70.6%
6
  75.0%
18
  72.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 17 participants 8 participants 25 participants
17 8 25
1.Primary Outcome
Title Glucose Tolerance at 24 Weeks
Hide Description
  1. Normal = normal plasma glucose and normal glucose tolerance (OGTT).
  2. Impaired category includes all non-diabetic participants with either a) Impaired fasting glucose = fasting plasma glucose >110 mg/dl and <126 mg/dl; or b) Impaired glucose intolerance = 2-hour plasma glucose (OGTT) >140 mg/dl and <200 mg/dl.
  3. Diabetes = fasting plasma glucose >126 mg/dl 2-hour (OGTT) plasma glucose >200 mg/dl.
Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sugar Pill (Placebo) Pioglitazone
Hide Arm/Group Description:

1 sugar pill (placebo) taken once daily for 48 weeks.

Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks.

30 mg pioglitazone (Actos) tablet taken once daily for 48 weeks.

Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks.

Overall Number of Participants Analyzed 7 16
Measure Type: Count of Participants
Unit of Measure: Participants
Diabetes
2
  28.6%
4
  25.0%
Impaired Glucose Tolerance
3
  42.9%
4
  25.0%
Normal
2
  28.6%
8
  50.0%
2.Primary Outcome
Title Glucose Tolerance at 48 Weeks
Hide Description
  1. Normal = normal plasma glucose and normal glucose tolerance (OGTT).
  2. Impaired category includes all non-diabetic participants with either a) Impaired fasting glucose = fasting plasma glucose >110 mg/dl and <126 mg/dl; or b) Impaired glucose intolerance = 2-hour plasma glucose (OGTT) >140 mg/dl and <200 mg/dl.
  3. Diabetes = fasting plasma glucose >126 mg/dl 2-hour (OGTT) plasma glucose >200 mg/dl.
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sugar Pill (Placebo) Pioglitazone
Hide Arm/Group Description:

1 sugar pill (placebo) taken once daily for 48 weeks.

Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks.

30 mg pioglitazone (Actos) tablet taken once daily for 48 weeks.

Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks.

Overall Number of Participants Analyzed 6 16
Measure Type: Count of Participants
Unit of Measure: Participants
Diabetes
2
  33.3%
5
  31.3%
Impaired Glucose Tolerance
2
  33.3%
5
  31.3%
Normal
2
  33.3%
6
  37.5%
3.Primary Outcome
Title Insulin Sensitivity Index for Glycemia at 24 Weeks
Hide Description

Insulin Sensitivity = Index for Glycemia (ISI gly) = 2 / ([INSp x GLYp] + 1).

GLYp = Glycemic 0-2 hr area = sum of normalized (based on institutional values) 0 & 2 hr glucose.

INSp = Insulinemic 0-2 hr area = sum of normalized (based on institutional values) 0 & 2 hr insulin.

Time Frame 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sugar Pill (Placebo) Pioglitazone
Hide Arm/Group Description:

1 sugar pill (placebo) taken once daily for 48 weeks.

Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks.

30 mg pioglitazone (Actos) tablet taken once daily for 48 weeks.

Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks.

Overall Number of Participants Analyzed 7 16
Mean (Standard Deviation)
Unit of Measure: numeric index
0.26  (0.11) 0.35  (0.20)
4.Primary Outcome
Title Insulin Sensitivity Index for Glycemia at 48 Weeks.
Hide Description

Insulin Sensitivity = Index for Glycemia (ISI gly) = 2 / ([INSp x GLYp] + 1).

GLYp = Glycemic 0-2 hr area = sum of normalized (based on institutional values) 0 & 2 hr glucose.

INSp = Insulinemic 0-2 hr area = sum of normalized (based on institutional values) 0 & 2 hr insulin.

Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sugar Pill (Placebo) Pioglitazone
Hide Arm/Group Description:

1 sugar pill (placebo) taken once daily for 48 weeks.

Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks.

30 mg pioglitazone (Actos) tablet taken once daily for 48 weeks.

Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks.

Overall Number of Participants Analyzed 6 16
Mean (Standard Deviation)
Unit of Measure: numeric index
0.21  (0.13) 0.36  (0.18)
5.Secondary Outcome
Title Beta-cell Function
Hide Description Homeostasis model assessment (HOMA 2) values generated using calculator at https://www.dtu.ox.ac.uk/homacalculator/
Time Frame 24, 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
1 participant on the placebo side was no longer participating at 48 weeks
Arm/Group Title Sugar Pill (Placebo) Pioglitazone
Hide Arm/Group Description:

1 sugar pill (placebo) taken once daily for 48 weeks.

Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks.

30 mg pioglitazone (Actos) tablet taken once daily for 48 weeks.

Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks.

Overall Number of Participants Analyzed 7 16
Mean (Standard Deviation)
Unit of Measure: Beta-cell function (%)
week 24 Number Analyzed 7 participants 16 participants
110.51  (31.59) 120.59  (48.78)
week 48 Number Analyzed 6 participants 16 participants
121.60  (61.53) 120.68  (44.39)
6.Secondary Outcome
Title Insulin Resistance at 24 and 48 Weeks
Hide Description Homeostasis model assessment (HOMA 2) values generated using calculator at https://www.dtu.ox.ac.uk/homacalculator/
Time Frame 24, 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
1 participant on the placebo side was no longer participating at 48 weeks
Arm/Group Title Sugar Pill (Placebo) Pioglitazone
Hide Arm/Group Description:

1 sugar pill (placebo) taken once daily for 48 weeks.

Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks.

30 mg pioglitazone (Actos) tablet taken once daily for 48 weeks.

Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks.

Overall Number of Participants Analyzed 7 16
Mean (Standard Deviation)
Unit of Measure: HOMA2-IR
24 weeks Number Analyzed 7 participants 16 participants
2.56  (1.29) 2.27  (1.00)
48 weeks Number Analyzed 6 participants 16 participants
2.32  (0.85) 2.42  (1.31)
7.Secondary Outcome
Title Pancreas Ultrasound Appearance
Hide Description

Mean score on a scale of 0 - 10: count of positive Endoscopic Ultrasound(EUS) features:

Parenchymal Features - Only Body and Tail

  1. Calcification (>3 hyperechoic foci >2 mm length & width with shadowing)
  2. Lobularity (>3 well-circumscribed, >5mm structures)
  3. Hyperechoic stranding (>3 hyperechoic lines >3mm in length, seen in > 2 different directions with respect to the imaged plane Parenchymal Features - Head, Body and Tail
  4. Cyst (>2 mm diameter anechoic round or oval structure)
  5. Hyperechoic foci (>3 reflectors, >3 mm long & wide, no shadowing) Ductal Features - Only Body and Tail
  6. Side Branch Dilation (>3 tubular, anechoic, >1 mm structures,Main pancreatic duct (MPD) connects)
  7. Irregular MPD contour (uneven and ectatic in its course)
  8. Hyperechoic MPD margin (hyperechoic in >50% of MPD)
  9. Dilation MPD (>3.5 mm body, >1.5 mm tail*) Ductal Features - Head, Body and Tail
  10. MPD calculi (hyperechoic foci with shadowing contained within MPD)
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sugar Pill (Placebo) Pioglitazone
Hide Arm/Group Description:

1 sugar pill (placebo) taken once daily for 48 weeks.

Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks.

30 mg pioglitazone (Actos) tablet taken once daily for 48 weeks.

Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks.

Overall Number of Participants Analyzed 6 16
Median (Inter-Quartile Range)
Unit of Measure: units on a scale
4.5
(4 to 5)
4.91
(3.5 to 6)
8.Secondary Outcome
Title Quality of Life
Hide Description The SF36 (Short Form with 36 questions) QoL scoring system has 36 questions, comprising two main dimensions (Physical Health and Mental Health), further divided by 8 independent scales (Physical functioning, Role-Physical, Bodily pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health). The scales for general health and mental health overlap components of both the two main dimensions (Physical Health and Mental Health). The scales, including the total score and dimensions are scored as a number between 0 and 100, where 0 represents lower limits of functioning and 100 is best functioning possible. Data reported is the average total score.
Time Frame 24, 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The 24 week data has two participants' data missing from each arm because it was not available.
Arm/Group Title Sugar Pill (Placebo) Pioglitazone
Hide Arm/Group Description:

1 sugar pill (placebo) taken once daily for 48 weeks.

Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks.

30 mg pioglitazone (Actos) tablet taken once daily for 48 weeks.

Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks.

Overall Number of Participants Analyzed 6 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
week 24 Number Analyzed 5 participants 14 participants
67.74  (29.13) 70.06  (18.86)
week 48 Number Analyzed 6 participants 16 participants
66.0  (26.33) 64.71  (23.54)
9.Secondary Outcome
Title Number and Percentage of Participants With Steatorrhea
Hide Description Participants were counted as having steatorrhea if they had either a) positive qualitative fecal fat; or b) 72 hour quantitative fecal fat result with >7g fat in stool in 24hours
Time Frame 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Sugar Pill (Placebo) Pioglitazone
Hide Arm/Group Description:

1 sugar pill (placebo) taken once daily for 48 weeks.

Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks.

30 mg pioglitazone (Actos) tablet taken once daily for 48 weeks.

Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks.

Overall Number of Participants Analyzed 6 16
Measure Type: Count of Participants
Unit of Measure: Participants
1
  16.7%
5
  31.3%
10.Secondary Outcome
Title Pain
Hide Description

Pain is reported as the mean of four Visual analogue scales, ranging from 0 points (no pain) to 100 points (severe pain)

  1. What is your pain right now?
  2. What is your typical or average pain in the last 12 weeks?
  3. What is your pain level at its best in the last 12 weeks (how close to “0” does your pain get at its best)?
  4. What is your pain level at its worst in the last 12 weeks (how close to “0” does your pain get at its worst)?
Time Frame 12, 24, 36, 48 and 60 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Some participant data is missing from some weeks, due to incomplete forms in certain instances.
Arm/Group Title Sugar Pill (Placebo) Pioglitazone
Hide Arm/Group Description:

1 sugar pill (placebo) taken once daily for 48 weeks.

Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks.

30 mg pioglitazone (Actos) tablet taken once daily for 48 weeks.

Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks.

Overall Number of Participants Analyzed 7 16
Mean (Standard Deviation)
Unit of Measure: units on a scale
week 12 Number Analyzed 6 participants 16 participants
19.38  (21.46) 23.03  (25.16)
week 24 Number Analyzed 7 participants 15 participants
26.32  (28.84) 18.92  (22.71)
week 36 Number Analyzed 6 participants 15 participants
22.88  (21.97) 23.55  (23.29)
week 48 Number Analyzed 6 participants 16 participants
25.42  (26.52) 27.50  (27.88)
week 60 Number Analyzed 5 participants 16 participants
13.15  (16.08) 26.11  (24.61)
11.Secondary Outcome
Title Body Mass Index (BMI)
Hide Description standard BMI defined as mass in kilograms divided by height in meters squared
Time Frame 12, 24, 36, 48 and 60 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Some participant data is missing from some weeks, due to incomplete forms in certain instances.
Arm/Group Title Sugar Pill (Placebo) Pioglitazone
Hide Arm/Group Description:

1 sugar pill (placebo) taken once daily for 48 weeks.

Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks.

30 mg pioglitazone (Actos) tablet taken once daily for 48 weeks.

Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks.

Overall Number of Participants Analyzed 6 16
Mean (Standard Deviation)
Unit of Measure: kg/m^2
12 weeks Number Analyzed 6 participants 16 participants
28.02  (5.73) 28.64  (6.88)
24 weeks Number Analyzed 5 participants 15 participants
25.56  (4.46) 29.49  (6.36)
36 weeks Number Analyzed 6 participants 14 participants
28.55  (5.92) 27.46  (6.01)
48 weeks Number Analyzed 6 participants 16 participants
28.26  (6.36) 28.75  (6.92)
60 weeks Number Analyzed 3 participants 14 participants
29.20  (4.36) 27.94  (6.77)
12.Secondary Outcome
Title Hospitalizations
Hide Description Mean number of hospitalizations within the prior 12 weeks
Time Frame 12, 24, 36, 48 and 60 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Some participant data is missing from some weeks, due to incomplete forms in certain instances.
Arm/Group Title Sugar Pill (Placebo) Pioglitazone
Hide Arm/Group Description:

1 sugar pill (placebo) taken once daily for 48 weeks.

Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks.

30 mg pioglitazone (Actos) tablet taken once daily for 48 weeks.

Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks.

Overall Number of Participants Analyzed 7 16
Mean (Standard Deviation)
Unit of Measure: hospitalizations
week 12 Number Analyzed 6 participants 16 participants
0  (0) 0.06  (0.25)
week 24 Number Analyzed 7 participants 16 participants
0.43  (1.13) 0.06  (0.25)
week 36 Number Analyzed 5 participants 15 participants
0.20  (0.45) 0.07  (0.26)
week 48 Number Analyzed 6 participants 16 participants
0  (0) 0.12  (0.34)
week 60 Number Analyzed 5 participants 16 participants
0  (0) 0.06  (0.25)
13.Secondary Outcome
Title Missed Work
Hide Description Mean days of missed work reported by participants in response to question asking about missed work since the last visit (12 weeks)
Time Frame 12, 24, 36, 48, 60 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Some participant data is missing from some weeks, due to incomplete forms in certain instances.
Arm/Group Title Sugar Pill (Placebo) Pioglitazone
Hide Arm/Group Description:

1 sugar pill (placebo) taken once daily for 48 weeks.

Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks.

30 mg pioglitazone (Actos) tablet taken once daily for 48 weeks.

Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks.

Overall Number of Participants Analyzed 7 16
Mean (Standard Deviation)
Unit of Measure: days
week 12 Number Analyzed 6 participants 16 participants
0.50  (1.20) 0  (0)
week 24 Number Analyzed 7 participants 16 participants
0.71  (1.89) 0.75  (2.52)
week 36 Number Analyzed 5 participants 15 participants
0.20  (0.45) 0.47  (1.36)
week 48 Number Analyzed 6 participants 16 participants
0  (0) 0.5  (1.75)
week 60 Number Analyzed 7 participants 16 participants
0  (0) 0.25  (1)
14.Secondary Outcome
Title Insulin Sensitivity (%S)
Hide Description Homeostasis model assessment (HOMA 2) values generated using calculator at https://www.dtu.ox.ac.uk/homacalculator/;
Time Frame 24 and 48 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
1 participant on the placebo side was no longer participating at 48 weeks
Arm/Group Title Sugar Pill (Placebo) Pioglitazone
Hide Arm/Group Description:

1 sugar pill (placebo) taken once daily for 48 weeks.

Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks.

30 mg pioglitazone (Actos) tablet taken once daily for 48 weeks.

Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks.

Overall Number of Participants Analyzed 7 16
Mean (Standard Deviation)
Unit of Measure: insulin sensitivity (%)
24 weeks Number Analyzed 7 participants 16 participants
45.39  (17.26) 51.83  (20.42)
48 weeks Number Analyzed 6 participants 16 participants
48.12  (17.21) 46.18  (26.86)
Time Frame 48 weeks
Adverse Event Reporting Description All adverse events that participants raised to study team as such, all of which were reported on to the IRB, are shown below.
 
Arm/Group Title Pioglitazone Sugar Pill (Placebo)
Hide Arm/Group Description

30 mg pioglitazone (Actos) tablet taken once daily for 48 weeks.

Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks.

1 sugar pill (placebo) taken once daily for 48 weeks.

Pioglitazone: Participants will be randomized to either pioglitazone or placebo. The dosing is 30 mg taken once daily for 48 weeks.

All-Cause Mortality
Pioglitazone Sugar Pill (Placebo)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Pioglitazone Sugar Pill (Placebo)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/17 (23.53%)      2/8 (25.00%)    
Ear and labyrinth disorders     
chronic vertigo exacerbation   1/17 (5.88%)  0/8 (0.00%) 
Endocrine disorders     
Hyperglycemia   0/17 (0.00%)  1/8 (12.50%) 
Gastrointestinal disorders     
Abdominal Pain   3/17 (17.65%)  8 1/8 (12.50%)  3
Nervous system disorders     
Trauma to head   1/17 (5.88%)  0/8 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pneumonia   1/17 (5.88%)  0/8 (0.00%) 
Skin and subcutaneous tissue disorders     
non-specific neck swelling   1/17 (5.88%)  0/8 (0.00%) 
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pioglitazone Sugar Pill (Placebo)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/17 (0.00%)      0/8 (0.00%)    
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Matthew DiMagno
Organization: University of Michigan
EMail: mdimagno@umich.edu
Layout table for additonal information
Responsible Party: Matthew DiMagno, MD, University of Michigan
ClinicalTrials.gov Identifier: NCT00782795     History of Changes
Other Study ID Numbers: CP-PENQEX-1R21AA017271
R21AA017271 ( U.S. NIH Grant/Contract )
1R21AA017271-01A1 ( U.S. NIH Grant/Contract )
First Submitted: October 29, 2008
First Posted: October 31, 2008
Results First Submitted: September 19, 2017
Results First Posted: December 11, 2017
Last Update Posted: January 11, 2018